Intravenous versus catheter directed thrombolytic therapy in non-traumatic acute limb ischemia

Effects of intravenous and catheter directed thrombolytic therapy with recombinant tissue plasminogen activator (Alteplase) in non-traumatic acute limb ischemia; a randomized double-blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014100719427N1

Enrollment

Registered

2015-07-07

Start date

2013-03-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obliteration of lower extremity arteries. Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere

Interventions

Intervention 1: Group 1: Alteplase 0.6 mg per kg intravenously in 2 hours. Half of the dosage would be given as bolus dose and the rest would be infused in 2 hours. Intervention 2: Group 2: Alteplase

Treatment - Drugs

Group 1: Alteplase 0.6 mg per kg intravenously in 2 hours. Half of the dosage would be given as bolus dose and the rest would be infused in 2 hours.

Group 2: Alteplase infusion via catheter directed route with 0.05 mg per kg per hour each 2 hours for 24 hours

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age 18 to 75 years; symptoms duration of 1 to 14 days; Acute limb ischemia (ALI) of grade IIa and IIb according to the Rutherford classification; absence of distal run off in angiography; Ankle-Brachial Index (ABI) less than 0.8 Exclusion criteria: Severe anemia (Hb less than 8 gr per dL); thrombocytopenia (platelet count less than 80000 per micl); low serum fibrinogen (fibrinogen less than 100 mg per dL); severe hypertension (systolic more than 160 mmHg, diastolic more than 100 mmHg); trauma or surgery less than 14 days before intervention; history of subarachnoid hemorrhage; life expectancy of less than 14 months; major internal bleeding less than 6 months before intervention; pregnancy; lumbar puncture 2 weeks before intervention

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Clinical condition. Timepoint: 1 week, 1, 3, 6, 12 months. Method of measurement: Rutherford classification; Pain severity measured by VAS; ABI.	—

Secondary

Measure	Time frame
Complete or near complete recanalization of the occluded artery. Timepoint: 12 months. Method of measurement: Angiography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Ravari

Mashhad University of Medical Sciences

ravarih@mums.ac.ir+98 51 3852 5311

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026